Legal status by country
Is TUDCA legal?
Written by Aaron CuhaReviewed Sep 2026
How TUDCA is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Not approved | Not approved | Not approved | Not approved |
| Classification | Sold as a supplement | Sold as a supplement | Available as a supplement / complementary medicine | Sold as a supplement |
| Note | Sold as a dietary supplement. The combination product containing it was approved for ALS and then withdrawn from the market by its sponsor after a failed phase 3 trial. Its parent compound, ursodeoxycholic acid, is a prescription medicine with its own entry on this site. | None recorded | None recorded | Sold as a natural health product. The ALS combination product's marketing authorisation was voluntarily withdrawn with Health Canada. |
US FDA status: Not approved as a single agent. A fixed combination of sodium phenylbutyrate and taurursodiol was FDA-approved for ALS and then voluntarily withdrawn by its sponsor after the phase 3 PHOENIX trial showed no change on the primary functional endpoint. TUDCA on its own is sold as a dietary supplement.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.